The WaveWriter Alpha SCS systems were already approved in the US and current FDA approval expands its indication to include the treatment of painful diabetic peripheral neuropathy (DPN) of the lower extremities for paresthesia-based stimulation
WaveWriter Alpha SCS systems. (Credit: Boston Scientific Corporation)
US-based biomedical engineering firm Boston Scientific has received the US Food and Drug Administration (FDA) expanded approval for its WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems.
The WaveWriter Alpha SCS systems were already approved in the US for the management of chronic intractable pain of the trunk or limbs.
The indication also includes unilateral or bilateral pain due to failed back surgery syndrome, complex regional pain syndrome types I and II, intractable low back pain and leg pain.
The current FDA approval expands its indication to include the treatment of painful diabetic peripheral neuropathy (DPN) of the lower extremities for paresthesia-based stimulation.
Boston Scientific neuromodulation president Jim Cassidy said: “The use of SCS to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world.
“This expanded indication is another testament to our commitment to delivering a robust portfolio of interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.”
WaveWriter Alpha SCS systems are a non-opioid treatment option for the treatment of chronic intractable pain of the lower extremities associated with DPN.
DPN is a complication of diabetes characterised by nerve damage throughout the body, often impacting the nerves in the lower extremities of the body, including the legs and feet.
Also, there are only limited alternatives for the management of pain related to DPN, which include pain-relieving medications.
The SCS system relieves pain by sending mild electric pulses to the spinal cord to interrupt the pain signals sent by the organ to the brain, said the medical device company.
Last month, Boston Scientific agreed to acquire privately held medical technology company Relievant Medsystems for an upfront payment of $850m in cash, along with additional contingent payments based on sales over the next three years.